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Inherited Genetic Susceptibility in Langerhans Cell Histiocytosis (LCH)
NCT04100408 · View on ClinicalTrials.gov ↗
Study Summary
The long-term goal is to define the mechanisms of pathogenesis underlying Langerhans cell histiocytosis (LCH). The overall objectives of the current study are to characterize the role of SMAD6 inherited genetic variation on LCH susceptibility and identify germline genomic regions associated with LCH somatic mutations. Building from preliminary data, the central hypotheses are: (1) causal genetic variants in SMAD6 underlie susceptibility to LCH, and (2) differences in LCH-related somatic activating mutations by race/ethnicity are related to Amerindian (i.e., Native American) genetic ancestry. The Central hypothesis will be tested by pursuing the specific aims.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- OTHER Biospecimen Collection
Study Locations (1)
Texas
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 647 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2026-09-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04100408
The ClinicalTrials.gov registry entry for NCT04100408 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 647 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Histiocytosis, Langerhans-Cell appearing as the primary indexed condition, and to 3 interventions — of which Laboratory Biomarker Analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04100408 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04100408 about?
NCT04100408 is a clinical study titled "Inherited Genetic Susceptibility in Langerhans Cell Histiocytosis (LCH)". The long-term goal is to define the mechanisms of pathogenesis underlying Langerhans cell histiocytosis (LCH). The overall objectives of the current study are to characterize the role of SMAD6 inherited genetic variation on LCH susceptibility and identify germline genomic regions associated with LCH...
What is the current status of trial NCT04100408?
This trial is currently active not recruiting. The enrollment target is 647 participants. The study started on 2020-06-01. Estimated completion is 2026-09-30.
What conditions does trial NCT04100408 study?
This clinical trial studies the following conditions: Histiocytosis, Langerhans-Cell. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04100408?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Biospecimen Collection (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04100408?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04100408 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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